Impact of Combined PSi + NIRS Monitoring in the Prevention of Postoperative Cognitive Disorders in Cardiac Surgery.

Prospective Randomized Controlled Study on the Impact of Combined PSi + NIRS Monitoring in the Prevention of Postoperative Cognitive Disorders in Cardiac Surgery.

Advances in cardiac medicine and anesthesia have made it possible to expand the indications for open heart surgery to increasingly older and more complex patients. This development is taking place in a demographic context where the aging of the world population has become a structural reality. However, postoperative neurocognitive complications, and in particular postoperative cognitive disorders (POCD), are not limited to the elderly. They can affect all adults, including younger adults, particularly in the presence of risk factors such as prolonged cardiopulmonary bypass, deep anesthesia, or episodes of intraoperative cerebral desaturation.

The PSi-NIRS study was designed with this broad perspective in mind. It will include all adult patients (≥18 years) eligible for cardiac surgery under extracorporeal circulation, with a secondary analysis dedicated to patients aged 65 years and older, a group in which POCD is more frequent, more long-lasting, and often has more serious consequences. This division will allow to assess the impact of cerebral monitoring both in the general adult population and within a well-defined geriatric subgroup.

The pathophysiological mechanisms involved in POCD are now better understood. On the one hand, insufficient cerebral oxygenation, even transient, can disrupt neuronal homeostasis for a prolonged period. On the other hand, excessively deep anesthesia, leading to periods of EEG suppression, is recognized as a risk marker for delirium and postoperative cognitive decline. These two dimensions - perfusion and cortical activity - constitute complementary targets for prevention.

Independently of each other, two tools available today - near-infrared spectroscopy (NIRS) and processed electroencephalography (PSi via SedLine®) - have shown their value in cardiac surgery. The use of NIRS to guide intraoperative adjustments has been associated with a reduction in neurological complications. Anesthetic guidance by EEG makes it possible to limit periods of suppression, linked to an increased risk of delirium and POCD. However, to date, no randomized study has evaluated the combined and coordinated use of these two modalities, with a predefined therapeutic algorithm allowing real-time clinical intervention based on critical thresholds.

The PSi-NIRS study is therefore part of a logic of scientific continuity, but takes a methodological step forward by testing for the first time an integrated and proactive approach to cerebral monitoring, applied to a surgical context with high neurological risk. It aims to verify whether this strategy can improve the postoperative cognitive trajectory of patients, in the short and medium term, by targeting the real points of intraoperative cerebral vulnerability.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Cognitive Disorders
• Intervention / Treatment: Device: NIRS (Near Infrared Spectroscopy); Device: SedLine®

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aimane MENIOUI, MD; Phone Number: 3224754103; Email: aimane.menioui@chu-brugmann.be

Study Locations

• Belgium
  • Brussels, Belgium, 1020
    • Recruiting
    • CHU Brugmann
    • Contact: Seyed Javad Bidgoli, MD; Phone Number: 003224772179; Email: SEYEDJAVAD.BIDGOLI@chu-brugmann.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Elective or relatively emergency surgery for valve surgery (pulmonary or tricuspid valves) or coronary artery bypass grafting (CABG)
• Preoperative cognitive assessment MoCA ≥ 20 (during the preoperative consultation if applicable or on day 1)
• ASA score II to IV

Exclusion Criteria:

• History of sequelae of stroke
• Diagnosis or strong suspicion of dementia (according to DSM-V criteria).
• Preoperative encephalopathy
• Severe chronic renal failure requiring dialysis
• Patients with chronic respiratory failure who are oxygen-dependent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard monitoring + NIRS; Dual intraoperative cerebral monitoring, consisting of; PSi (Patient State Index) via SedLine®, an indicator of anesthetic depth (normal values between 25 and 50),; NIRS (Near Infrared Spectroscopy), real-time measurement of regional cerebral oxygenation, associated with a standardized therapeutic algorithm.	Device: NIRS (Near Infrared Spectroscopy); Real-time measurement of regional cerebral oxygenation.; Device: SedLine®; The SedLine® Brain Function Monitoring device (Masimo Corporation, model RDS7A, CE certified) uses four forehead electrodes to record EEG activity. The Patient State Index (PSi), calculated in real time, is interpreted within a target range of 25 to 50 to ensure adequate general anesthesia. The device complies with international standards for electrical safety (IEC 60601) and hospital use.
Active Comparator: Standard monitoring; Intraoperative cerebral monitoring, consisting of PSi (Patient State Index) via SedLine®.	Device: SedLine®; The SedLine® Brain Function Monitoring device (Masimo Corporation, model RDS7A, CE certified) uses four forehead electrodes to record EEG activity. The Patient State Index (PSi), calculated in real time, is interpreted within a target range of 25 to 50 to ensure adequate general anesthesia. The device complies with international standards for electrical safety (IEC 60601) and hospital use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MoCA (Montreal Cognitive Assessment)	Rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.The total possible score is 30 points; a score of 26 or above is considered normal.	Baseline, pre-surgery
MoCA (Montreal Cognitive Assessment)	Rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.The total possible score is 30 points; a score of 26 or above is considered normal.	2 days post surgery
MoCA (Montreal Cognitive Assessment)	Rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.The total possible score is 30 points; a score of 26 or above is considered normal.	7 days post surgery
MoCA (Montreal Cognitive Assessment)	Rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.The total possible score is 30 points; a score of 26 or above is considered normal.	25 days post surgery
MoCA (Montreal Cognitive Assessment)	Rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.The total possible score is 30 points; a score of 26 or above is considered normal.	30 days post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative length of stay	Postoperative length of stay	Immediately after the surgery
Cumulative duration of burst deletions (SedLine)		During the surgery
Cumulative duration of NIRS desaturation episodes		During the surgery

Collaborators and Investigators

• Sponsor: Brugmann University Hospital
• Investigators: Principal Investigator: Aimane MENIOUI, MD, CHU Brugmann

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2026

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Actual): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Postoperative Complications; Pathologic Processes; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Pathological Conditions, Signs and Symptoms; Postoperative Cognitive Complications; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Chemistry Techniques, Analytical; Spectrum Analysis; Spectroscopy, Near-Infrared
• Other Study ID Numbers: PsiNIRS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No